BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDICATH CH10 FEMALE

    MDR report key: 1915853 · Received December 6, 2010

    Report

    Report Number
    9610694-2010-00023
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Report Date
    June 28, 2010
    Manufacturer
    COLOPLAST A/S
    Product Code
    GBM
    PMA / PMN Number
    K023254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT RETURNED. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURENCE.

    Description of Event or Problem · 1

    (B)(6).ACCORDING TO THE INFORMATION RECIEVED, A PHARMACY REPORTED THAT THERE WAS A BOX OF 10 FRENCH CATHETERS THAT CONTAINED 14 FRENCH CATHETERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPEEDICATH CH10 FEMALE INTERMITTENT CATHETER GBM COLOPLAST A/S 2851001001 2346219

    Patients

    Seq Age Sex Outcome Treatment
    1